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New hope for Men's bones: prolia study targets osteoporosis in china

NCT ID NCT06332014

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the drug Prolia works for men with osteoporosis in mainland China. About 102 men aged 30 to 90 with weak bones will receive Prolia injections. The main goal is to see if bone density in the lower spine improves after 12 months of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

102 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 90 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent. * Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture. * Have to have at least two intact vertebrae at baseline (L1-L4). Exclusion Criteria: * Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed). * Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed. * Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed). * Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol. * Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months. * Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization. * Oral bisphosphonates treatment. * Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or cirrhosis of the liver. * Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason. * Oral/dental conditions that would require an intervention including tooth extraction during the course of the study and invasive dental work (per local oral surgeon's assessment) planned in the next 12 months. * Any prior use of products containing denosumab. * Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Vitamin D levels \< 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened). * Albumin-adjusted serum calcium levels \< 8.5 mg/dl or \> 10.5 mg/dl.

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Conditions

The condition(s) this trial relates to.

osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

Contacts and locations

Locations

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035, China

  • Huaian First Peoples Hospital

    Huaian, Jiangsu, 223300, China

  • Jiangxi Provincial Peoples Hospital

    Nanchang, Jiangxi, 330038, China

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Pingxiang Peoples Hospital

    Pingxiang, Jiangxi, 337000, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Shanghai Sixth Peoples Hospital

    Shanghai, 200233, China

  • Sun Yat-sen Memorial Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Peoples Hospital of Kunshan

    Suzhou, Jiangsu, 215300, China

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.